Synthego Receives ISO 9001:2015 Certification as Seal of Quality Standard for GMP-Grade CRISPR Gene Editing

MENLO PARK, Calif., May 12, 2021 – Synthego, the genome engineering company, today announced it has obtained ISO 9001:2015 certification based on the quality standard requirements published by the International Organization for Standardization (ISO). This certification resulted from a comprehensive independent audit of the company’s entire manufacturing process for GMP-grade single-guide RNA (sgRNA) used by biopharma customers for the research and development of gene therapeutics and CRISPR-based gene editing. ISO-certified capabilities reinforce Synthego’s position as the key accelerator of the entire continuum of therapeutic development in biopharma from early research to clinical trials.

ISO 9001 is an internationally recognized standard that specifies requirements for a quality management system and demonstrates that an organization has the ability to consistently provide products and services that meet customer and regulatory requirements.

"This certification solidifies Synthego as the top-quality genome engineering company," said John Tan, chief operating officer, Synthego. "We look forward to continuing to industrialize CRISPR-based gene editing and cell engineering, enabling thousands of our customers to drive innovation and R&D transformation in cell and gene therapeutics."

Achieving ISO 9001 certification means that Synthego’s quality management system, GMP manufacturing process, customer service, and documentation procedures met or exceeded all requirements according to the British Standards Institution (BSI), an ISO-accredited notified body responsible for assessing compliance and issuing the certification.

For customers, this achievement demonstrates that GMP sgRNA manufacturing under Synthego’s quality management systems will provide products and related services that consistently meet customer needs and applicable regulatory requirements. According to the ISO website,  "ISO 9001 allows organizations to adapt to a changing world. It enhances an organization’s ability to satisfy its customers and provides a coherent foundation for growth and sustained success."